BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE PLUS TEST STRIPS

    MDR report key: 1071311 · Received July 8, 2008

    Report

    Report Number
    1823260-2008-05255
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 15, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT A PERITONEAL DIALYSIS PT EXPERIENCED HYPOGLYCEMIA COINCIDENT WITH EXTERNAL THERAPY (A LABELED INTERFERENT FOR THE TEST STRIPS). REPORTER STATED THAT PT'S BLOOD GLUCOSE WAS MEASURED AT 6:00 AM, USING THE ADVANTAGE SYSTEM, WITH A RESULT OF 5.6 MMOL/L. TWO HOURS LATER, PT WAS REPORTEDLY FOUND WITH SLURRED SPEECH. NO TREATMENT WAS REPORTED AT THIS TIME. AT 9:40 AM, PT'S BLOOD GLUCOSE WAS REPORTEDLY RETESTED ON THE ADVANTAGE SYSTEM WITH A RESULT AND 5.5.MMOL/L. REPORTER STATED THAT, AT 10:10 AM, AN ADD'L SAMPLE WAS OBTAINED FROM THE PT AND WAS SENT TO THE FACILITY'S LAB FOR TESTING. AT 10:45 AM, PT WAS REPORTEDLY UNRESPONSIVE. AGAIN NO TREATMENT WAS REPORTED. REPORTER STATED THAT PT'S BLOOD GLUCOSE WAS MEASURED AT 11:30 AM, USING THE ADVANTAGE SYSTEM, WITH A RESULT OF 5.5 MMOL/L. AT 12:30 PM, THE LAB REPORTED THAT PT'S BLOOD GLUCOSE WAS 1.2 MMOL/L. FIFTEEN MINUTES LATER, PT'S GLUCOSE WAS RETESTED ON THE ADVANTAGE SYSTEM WITH A RESULT OF 4.8 MMOL/L. NO TREATMENT WAS REPORTED AT THIS TIME. AT 1:45 PM, PT WAS REPORTEDLY TREATED WITH 50% GLUCOSE SOLUTION (AMOUNT AND ADMINISTRATION ROUTE NOT PROVIDED). AT 2:09 PM, AN ADD'L SAMPLE WAS SENT TO THE LAB FOR TESTING. AN UNSPECIFIED TIME LATER, THE LAB REPORTED THAT PT'S BLOOD GLUCOSE WAS 1.3 MMOL/L. AT 2:45 PM, PT'S BLOOD GLUCOSE MEASURED 14.6 MMOL/L ON THE ADVANTAGE SYSTEM. REPORTER DID NOT INDICATE IF PT RECEIVED ANY ADD'L TREATMENT FOR HYPOGLYCEMIA. NO INFO ABOUT PT OUTCOME FOLLOWING THE EVENT WAS PROVIDED. NO PRODUCT WAS RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-NA NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EXTRANEAL| DIANEAL